510(k) K992432 ยท MDB System, Blood Culturing
BACT/ALERT FN
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Sep 24, 1999 |
| Received | Jul 21, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992432
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2007 | bioMerieux, Inc. BacT/ALERT FN Culture Bottles, Product Number 259793 Terminated |
MBD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.